Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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CTRI |
Last refreshed on:
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24 November 2021 |
Main ID: |
CTRI/2017/01/007727 |
Date of registration:
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20-01-2017 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Study of Nintedanib and Sildenafil in advanced IPF patients.
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Scientific title:
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A 24-week, double-blind, randomized, parallel-group study evaluating the
efficacy (health related quality of life assessment) and safety of oral nintedanib coadministered
with oral sildenafil, compared to treatment with nintedanib alone, in patients
with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment. - INSTAGE |
Date of first enrolment:
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23-01-2017 |
Target sample size:
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250 |
Recruitment status: |
Not Yet Recruiting |
URL:
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http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=15347 |
Study type:
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Interventional |
Study design:
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Randomized, Parallel Group, Active Controlled Trial Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
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Phase:
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Phase 3/ Phase 4
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Countries of recruitment
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Australia
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Belgium
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Canada
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China
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France
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Germany
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India
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Italy
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Japan
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Mexico
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Spain
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United Kingdom
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United States of America
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Contacts
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Name:
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Dr Partha Gokhale
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Address:
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Boehringer Ingelheim
1102 Hallmark Business Plaza
Gurunanak Hospital Road Bandra East, Mumbai
400051
Mumbai, MAHARASHTRA
India |
Telephone:
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912226456477 |
Email:
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partha.gokhale@boehringer-ingelheim.com |
Affiliation:
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Boehringer Ingelheim India Private Limited |
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Name:
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Dr Partha Gokhale
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Address:
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Boehringer Ingelheim
1102 Hallmark Business Plaza
Gurunanak Hospital Road Bandra East Mumbai Boehringer Ingelheim India Pvt Ltd
1102 Hallmark Business Plaza
Gurunanak Hospital Road Bandra East
400051
Mumbai, MAHARASHTRA
India |
Telephone:
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912226456477 |
Email:
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partha.gokhale@boehringer-ingelheim.com |
Affiliation:
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Boehringer Ingelheim India Private Limited |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1 Written informed consent consistent with ICH-GCP and local laws signed prior to
any study procedures being performed including any required washout
2 Male or female patients aged more than or equal to 40 years at visit 1
3 A clinical diagnosis of IPF within the last 6 years before visit 1 based upon the
ATS ERS JRS ALAT 2011 guideline
4 Combination of high resolution computed tomography HRCT pattern and if
available surgical lung biopsy pattern consistent with a diagnosis of IPF as assessed by the investigator based on a HRCT scan performed
within 18 months of visit 1
5 DLCO corrected for Hb less than or equal to 35 percent predicted of normal at visit 1
Exclusion criteria: 1 Previous enrolment in this trial
2 ALT AST more than 1.5 fold upper limit of normalat visit 1
3 Total bilirubin more than 1.5 fold ULN at visit 1
4 Relevant airways obstruction pre-bronchodialator FEV1/FVC less than 0.7 at visit 1
5 History of myocardial infarction within 6 months of visit 1 or unstable angina within
1 month of visit 1
6 Bleeding Risk
Known genetic predisposition to bleeding
Patients who require fibrinolysis full dose therapeutic anticoagulation or
high dose antiplatelet therapy
History of haemorrhagic central nervous system event within 12 months prior to visit 1
History of haemoptysis or haematuria active gastrointestinal bleeding or
ulcers and or major injury or surgery within 3 months prior to visit 1
International normalised ratio more than 2 at visit 1
Prothrombin time and activated partial thromboplastin time more than
150 percent of institutional ULN at visit 1
7 Planned major surgery during the trial participation including lung transplantation
major abdominal or major intestinal surgery
8 History of thrombotic event within 12
months of visit 1
9 Creatinine clearance less than 30 mL per min calculated by CockcroftGault formula
10 Presence of aortic stenosis per investigator judgement at visit 1
11 Severe chronic heart failure defined by left ventricular ejection fraction < 25 percent
per investigator judgement at visit 1
12 Presence of idiopathic hypertrophic subaortic stenosis (IHSS) per investigator
judgement at visit 1
13 Second-degree or third-degree atrioventricular (AV) block on electrocardiogram
(ECG) per investigator judgement at visit 1
14 Hypotension (systolic blood pressure [SBP] < 100 mm Hg or diastolic blood pressure
[DBP] < 50 mm Hg) (symptomatic orthostatic hypotension) at visit 1
15 Uncontrolled systemic hypertension (SBP > 180 mmHg; DBP > 100 mmHg) at visit
1
16 Known penile deformities or conditions (e.g., sickle cell anemia, multiple myeloma,
leukemia) that may predispose to priapism
17 Retinitis pigmentosa
18 History of vision loss
19 History of nonarteritic ischemic optic neuropathy
20 Veno-occlusive disease
21 History of acute IPF exacerbation or respiratory infection within 8 weeks of visit 2
22 Treatment with nitrates, n-acetylcysteine, pirfenidone, azathioprine,
cyclophosphamide, cyclosporine, prednisone >15 mg daily or >30 mg every 2 days
OR equivalent dose of other oral corticosteroids as well as any investigational drug
within 4 weeks of visit 2
23 Treatment for pulmonary hypertension with prostaglandins (e.g., epoprostenol,
treprostinil), endothelin-1 antagonists (e.g., bosentan, sitaxsentan, ambrisentan),
phosphodiesterase inhibitors (e.g., sildenafil, tadalafil, vardenafil) or a stimulator of
guanylatcyclase (e.g., riociguat) within 4 weeks of visit 2
24 Treatment with potent CYP3A4 inhibitors such as ketoconazole, itraconazole and
ritonavir within 4 weeks of visit 2
25 Supplementation with L-arginine and concurrent use of grapefruit juice or St Johnâ??s
wort within 4 weeks of visit 2
26 Treatment with the reduced dose of nintedanib (100 mg bid) within 4 weeks of visit
2
27 Permanent discontinuation of nint
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Health Condition 1: null- Idiopathic Pulmonary Fibrosis
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Intervention(s)
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Intervention1: Nintedanib: Will receive nintedanib 150mg twice daily orally for 24 weeks Control Intervention1: Nintedanib and Sildenafil: Will receive nintedanib 150mg twice daily orally for 24 weeks and Sildenafil 20mg thrice daily orally for 24 weeks
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Primary Outcome(s)
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Change from baseline in SGRQ total scoreTimepoint: 12 Week
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Secondary Outcome(s)
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Change from baseline in dyspnea using UCSD SOBQ
Change from baseline in SGRQ total score
Change from baseline in dyspnea using UCSD SOBQ
Percentage of patients with on-treatment SAEs from baselineTimepoint: 24 Week
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Source(s) of Monetary Support
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Boehringer Ingelheim India Pvt Ltd, 1102, Hallmark Business Plaza, Near Gurunanak
Hospital, Gurunanak Hospital Road, Bandra (E), Mumbai 400051
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Ethics review
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Status: Approved
Approval date: 18/10/2016
Contact:
Getwell Institutional Ethics Committee (GIEC)
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Status: Approved
Approval date: 29/10/2016
Contact:
Sanjivani Hospital Ethics Committee
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Status: Approved
Approval date: 07/11/2016
Contact:
Ethics Committee Jehangir Clinical development Centre Pvt. Ltd
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Status: Approved
Approval date: 14/11/2016
Contact:
Ethics Committee of Care Institute of Medical Sciences
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Status: Not Approved
Approval date:
Contact:
Ethics Committee AIIMS
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Status: Not Approved
Approval date:
Contact:
Ethics Committee of Bangalore Medical College and Research Institute
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Status: Not Approved
Approval date:
Contact:
Institutional Human Ethics Committee
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Status: Not Approved
Approval date:
Contact:
Institutional Ethics Committee Fortis Hospital
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Status: Not Approved
Approval date:
Contact:
Institutional Ethics Committee of B J Medical Government College, Sassoon General Hospital
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Status: Not Approved
Approval date:
Contact:
Institutional Ethics Committee of PGI Chandigarh
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Status: Not Approved
Approval date:
Contact:
Institutional Ethics Committee Poona Medical Research Foundation
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Status: Not Approved
Approval date:
Contact:
Kamineni Institutional Ethics Committee
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Status: Not Approved
Approval date:
Contact:
MAC MET Ethics Committee
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Status: Not Approved
Approval date:
Contact:
St Johns Medical College and Hospital Institutional Ethics Commmittee
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Status: Not Approved
Approval date:
Contact:
Vikram Hospital Bengaluru Private limited Ethics Committee
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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